Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery (NCT00002807) | Clinical Trial Compass
CompletedNot Applicable
Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
United States, Australia, Canada116 participantsStarted 1996-07-04
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known whether radiation therapy is more effective than observation only after sugery in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to observation only in treating patients with stage I or stage II endometrial cancer who have undergone hysterectomy and oophorectomy.
Who can participate
Age range120 Years
SexFEMALE
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DISEASE CHARACTERISTICS:
* Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium
* Intermediate-risk of recurrence after laparoscopically-assisted vaginal hysterectomy (with or without laparoscopic staging) or total abdominal hysterectomy and bilateral salpingo-oophorectomy
* Postoperative pathologic stage IA/IB (grade 3), stage IC (grade 1-3), or stage IIA (all grades)
* Patients with more than 50% myometrial invasion (grade 1 or 2) or less than 50% myometrial invasion (grade 3) but with positive peritoneal cytology also eligible
* Patients whose sole criterion for increased risk is positive peritoneal cytology are not eligible
* No pathologically involved lymph nodes if staging procedure performed
* Stage I papillary serous or clear cell endometrial cancer allowed
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* ECOG 0-3
Life expectancy:
* At least 3 years
Hematopoietic:
* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Not specified
Renal:
* Creatinine less than 2 times upper limit of normal
* No serious renal disease that would preclude radiotherapy
Cardiovascular:
* No serious cardiovascular disease that would preclude radiotherapy
Other:
* No history of inflammatory bowel disease such as ulcerative colitis
* No other malignancy within past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of tā¦